FDA Adverse Event
Malfunction
Summary report: N
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
MDR report key: 3050471
·
Received April 10, 2013
Report
- Report Number
- 3005099803-2013-02302
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 15, 2013
- Report Date
- March 15, 2013
- Manufacturer
- BOSTON SCIENTIFIC - FREMONT (CE)
- Product Code
- MNB
- PMA / PMN Number
- P000040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER THE CONSOLE WAS SET UP FOR THE PROCEDURE. THE BUTTON WAS PRESSED TO ADVANCE TO FILL SYSTEM AND THE MACHINE SKIPPED TO THE LAST SCREEN AND SHUT DOWN. ADDITIONALLY, IT WAS REPORTED THAT SALINE WAS NOTED TO BE LEAKING FROM THE CASSETTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER INSTALLING A SECOND PROCEDURE SET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152192 | HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM | DEVICE, THERMAL ABLATION, ENDOMETRIAL | MNB | BOSTON SCIENTIFIC - FREMONT (CE) | M006580010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |